CDS Developer
Core
Designing, modifying, and documenting clinical databases and supporting systems for electronic Case Report Forms (eCRFs) to support clinical trials.
Role type
Clinical Data Systems (CDS) Developer
Builds
Clinical databases and edit check programming for global data management services
Domain
Clinical research and clinical trials
Deliverable
production ML models | product features | dashboards & analysis | infrastructure
Required skills
Clinical database development, Clinical Data Management Systems (Inform, Inform Architect, Central Designer), SQL/PL-SQL, Oracle databases, FDA regulations, GxP guidelines, ICH guidelines, 21 CFR Part 11, Clinical Development process
Preferred skills
Python programming, Data visualization, Artificial Intelligence (AI), eCRF design
Technologies
Inform, Inform Architect, Central Designer, SQL, PL/SQL, Oracle, MS Windows/Office
Responsibilities
Design and implement clinical databases with electronically captured data for protocol startup; Review technical feasibility and implement study team proposed edit checks; Manage change requests and incidence corrections into clinical databases; Participate in study improvement task forces, system testing, and mentoring
Seniority
Mid-level, hands-on IC